Medication info
Cefuroxime Axetil Tablet (Cefuroxime Axetil)

Cefuroxime Axetil Tablet (Cefuroxime Axetil)

Prescription medicationTabletOral
Ingredient · strength
Cefuroxime Axetil›300.72mg / 1 tablet
Manufacturer / importer
KIPS Biopharma Co., Ltd.
Appearance
White oblong film-coated tablets
Packaging
50 tablets/box [(10 tablets/PTP X 5)], 100 tablets/box [(10 tablets/PTP X 10)]
Approval status
Active

MFDS item code 201403735 · Approved 2014.08.12 · Insurance code 693201000

Summary

Main use
Treatment of respiratory, genitourinary, and skin and soft tissue infections, gonorrhea, and early Lyme disease
Who takes it
Adults · Children
Adult dose
For optimal absorption, take after meals. For treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), administer this medicine for 7~10 days. 3. Patients with renal impairment Cefuroxime is primarily eliminated by the kidneys. To compensate for delayed elimination in patients with significantly impaired renal function, cefuroxime dose reduction as shown below is recommended. Creatinine clearance T1/2 (hours) Recommended dose ≥ 30 mL/min/1.73m2 1.4 - 2.4 No dose adjustment required (Standard dose: 125mg-500mg per dose twice daily) 10 - 29 mL/min/1.73m2 4.6 Administer a standard single dose every 24 hours < 10 mL/min/1.73m2 16.8 Administer a standard single dose every 48 hours Patients on hemodialysis 2 - 4 Administer an additional standard single dose at the end of each dialysis session
Child dose
Age 12 years and older: Most infections — administer 250mg twice daily. Age 12 years and older: Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by organisms with reduced susceptibility — administer 500mg twice daily. Age 12 years and older: Urinary tract infections — administer 250mg twice daily. Age 12 years and older: Uncomplicated gonorrhea — administer a single dose of 1g. Age 12 years and older: Lyme disease — administer 500mg twice daily for 14 days (10~21 days). Infants and children under 12 years: Most infections — administer 125mg twice daily. Children aged 2 years and older: Otitis media and severe infections — administer 250mg twice daily. Infants and children under 12 years: Lyme disease — administer 250mg twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age. This medicine should not be divided and is therefore not suitable for treating patients, such as young children, who cannot swallow tablets.

Ingredients

Manufacturer
KIPS Biopharma Co., Ltd.

Efficacy & effects

Treatment of respiratory, genitourinary, and skin and soft tissue infections, gonorrhea, and early Lyme disease

  • Otitis media
  • sinusitis
  • tonsillitis
  • pharyngitis
  • acute bronchitis
  • chronic bronchitis
  • pneumonia
  • pyelonephritis
  • cystitis
  • urethritis
  • furunculosis
  • impetigo
View approved original text

Cefuroxime is a broad-spectrum antibiotic effective against various bacteria, used for upper respiratory infections (otitis media, sinusitis, tonsillitis, pharyngitis), lower respiratory infections (acute and chronic bronchitis, pneumonia), urogenital infections (pyelonephritis, cystitis, urethritis), skin and soft tissue infections (furuncles, abscesses, impetigo), gonorrhea, and early Lyme disease. This medication is highly stable against beta-lactamases and effective against strains resistant to ampicillin or amoxicillin. In other words, it helps improve and treat symptoms caused by various bacterial infections. It is a medication that can be safely used for treatment.

How to take

Adult dose

For optimal absorption, take after meals. For treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), administer this medicine for 7~10 days. 3. Patients with renal impairment Cefuroxime is primarily eliminated by the kidneys. To compensate for delayed elimination in patients with significantly impaired renal function, cefuroxime dose reduction as shown below is recommended. Creatinine clearance T1/2 (hours) Recommended dose ≥ 30 mL/min/1.73m2 1.4 - 2.4 No dose adjustment required (Standard dose: 125mg-500mg per dose twice daily) 10 - 29 mL/min/1.73m2 4.6 Administer a standard single dose every 24 hours < 10 mL/min/1.73m2 16.8 Administer a standard single dose every 48 hours Patients on hemodialysis 2 - 4 Administer an additional standard single dose at the end of each dialysis session

Child dose

Age 12 years and older: Most infections — administer 250mg twice daily. Age 12 years and older: Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by organisms with reduced susceptibility — administer 500mg twice daily. Age 12 years and older: Urinary tract infections — administer 250mg twice daily. Age 12 years and older: Uncomplicated gonorrhea — administer a single dose of 1g. Age 12 years and older: Lyme disease — administer 500mg twice daily for 14 days (10~21 days). Infants and children under 12 years: Most infections — administer 125mg twice daily. Children aged 2 years and older: Otitis media and severe infections — administer 250mg twice daily. Infants and children under 12 years: Lyme disease — administer 250mg twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age. This medicine should not be divided and is therefore not suitable for treating patients, such as young children, who cannot swallow tablets.

Precautions

This medication should not be administered to patients with an allergy to cephalosporin antibiotics. Patients with a history of allergy to penicillins or other beta-lactam antibiotics, those with allergic predispositions, patients with severe renal impairment, and elderly patients or those who have difficulty swallowing should use it with caution. When taking this medication, symptoms of hypersensitivity such as rash, hives, or difficulty breathing should be carefully observed, and in severe cases, administration should be stopped immediately. Side effects such as headaches, dizziness, diarrhea, and nausea may occur, and if these symptoms persist, consultation with a healthcare professional is required. Prolonged use may lead to excessive growth of Candida or non-susceptible bacteria, so caution is advised. If diarrhea or abdominal pain worsens, serious intestinal conditions such as pseudomembranous colitis may occur, and immediate notification to a healthcare professional is required. This medication may cause dizziness, so caution is advised when driving or operating machinery. Pregnant or breastfeeding women should only use it after consulting with their doctor, and caution is particularly advised during early pregnancy. Children, especially infants under 3 months, have not established safety, so caution is necessary, and it is recommended to administer it in syrup form due to the bitterness for younger children. Elderly patients may have an increased risk of bleeding due to impaired renal function and vitamin K deficiency, requiring dose adjustment and monitoring of their condition. This medication may interact with other drugs, so inform healthcare professionals when taking diuretics, aminoglycoside antibiotics, antacids, probenecid, or oral contraceptives together. In cases of overdose, convulsions may occur, and immediate hospitalization is required, with the possibility of lowering the drug concentration through hemodialysis or peritoneal dialysis. This medication should be kept out of reach of children and stored in its original container to maintain quality.

Side effects

  • Candidiasis hyperproliferation
  • eosinophilia
  • positive Coombs test
  • thrombocytopenia
  • leukopenia
  • neutropenia
  • anemia
  • decreased hemoglobin
  • decreased hematocrit
  • hemolytic anemia
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  • skin rash
  • urticaria
  • itching
  • drug fever
  • serum sickness
  • anaphylaxis
  • facial edema
  • lymphadenopathy
  • arthralgia
  • headache
  • dizziness
  • diarrhea
  • nausea
  • abdominal pain
  • vomiting
  • dyspepsia
  • constipation
  • loss of appetite
  • pseudomembranous colitis
  • abdominal distension
  • fever
  • cough
  • dyspnea
  • chest X-ray abnormalities
  • temporary increase in liver enzymes
  • jaundice
  • hepatitis
  • elevated BUN
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B complex deficiency
  • otalgia
  • perioral sensory disturbances
  • tongue numbness
  • pharyngeal abnormalities
  • dry mouth
  • palpitations
  • eczema
  • Churg-Strauss syndrome
  • DRESS syndrome
  • malaise
  • oral abnormalities
  • wheezing
  • fecal incontinence
  • tinnitus
  • sweating
  • convulsions

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is also best to store it at room temperature between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

White oblong film-coated tablets

Package unit

50 tablets/box [(10 tablets/PTP X 5)], 100 tablets/box [(10 tablets/PTP X 10)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.